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The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00375505
First received: September 11, 2006
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment


Condition Intervention Phase
Breast Cancer
Drug: Zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in bone mineral density (BMD) measured by DXA at lumbar spine (L2-L4) between baseline and 24 months [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density (BMD) measured by DXA at dual hips and os calcis after 24 months [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Bone mineral density (BMD) measured by QUS at os calcis and phalanges after 24 months [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2005
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOL446 3 monthly Drug: Zoledronic acid
Other Name: ZOL446
Placebo Comparator: Placebo Drug: Zoledronic acid
Other Name: ZOL446

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)
  • Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
  • Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/dL)
  • Patient receives adjuvant standard chemoendocrine or endocrine therapy
  • Bone density at study entry > -2.5 T-Score

Exclusion Criteria:

  • History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D
  • Abnormal renal function
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
  • Pregnancy or lactation
  • Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375505

Locations
Germany
Novartis Investigative Site
Marburg, Germany, 35043
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00375505     History of Changes
Other Study ID Numbers: CZOL446GDE21
Study First Received: September 11, 2006
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Breast Cancer
Premenopausal
Bone mineral density
Cancer therapy induced bone loss
zoledronic acid

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014